Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-04 @ 8:37 AM
Study NCT ID:
NCT01775995
Status:
COMPLETED
Last Update Posted:
2016-05-16
First Post:
2013-01-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Meditation-CBT for Opioid-treated Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001416', 'term': 'Back Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D019122', 'term': 'Meditation'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aleksandra.zgierska@fammed.wisc.edu', 'phone': '(608) 263-7882', 'title': 'Aleksandra Zgierska, MD PhD', 'organization': 'University of Wisconsin Madison'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Lack of blinding of study staff to group status (except the statistician who was blinded during initial primary analyses); conducting most study related activities by the same core group of research staff may have introduced bias and placebo effect.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Experimental: Meditation-CBT', 'description': 'Mindfulness-CBT + Standard of Care Therapy\n\nMindfulness Based Intervention with Cognitive Behavioral Therapy (CBT) components: All study subjects receive standard of care therapy. In addition, experimental subjects receive the mindfulness-CBT. The intervention consists of an 8-week meditation-CBT course (2 hour weekly group sessions) and daily, at-home practice (30 mins/day, 6 days/week of formal practice). Controls will be offered meditation intervention after completing the study.', 'otherNumAtRisk': 21, 'otherNumAffected': 7, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Wait-list Control', 'description': 'Standard of Care Therapy only', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Increased cigarette smoking', 'notes': 'One participant reported increased cigarette smoking during the meditation course (course started on 3-25-13), however, prior to the end of the course this individual reported they were able to quit smoking altogether (on 5-1-13).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight gain', 'notes': 'One participant reported an increase in weight during the meditation course (course started on 3-25-13), however after the end of the course the participant reported their weight decreased again (on 5-21-13).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased pain', 'notes': "Two participants reported increased pain with mindful movement or when learning to mindfully 'observe' pain experiences, during the meditation course (course started on 3-25-13 and ended on 5-13-13).", 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety/Emotional Distress', 'notes': 'Three participants reported increased anxiety or emotional distress while learning the meditation intervention techniques during the course (course started on 3-25-13 and ended on 5-13-13).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Health-Related Quality of Life: Averaged Pain Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '0.03'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '1.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 8 weeks', 'description': 'Averaged pain is the average of 4 responses on a 0-10 numerical rating scale (0=no pain; 10=worst possible pain) from the Brief Pain Inventory (BPI): 1) describe your pain at its worst in the last week 2) describe your pain at its least in the last week 3) describe your pain on the average 4) describe your pain right now.\n\nThis outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased pain and negative values indicating decreased pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.'}, {'type': 'PRIMARY', 'title': 'Health-Related Quality of Life: Averaged Pain Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '0.02'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '1.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 26 weeks', 'description': 'Averaged pain is the average of 4 responses on a 0-10 numerical rating scale (0=no pain; 10=worst possible pain) from the Brief Pain Inventory (BPI): 1) describe your pain at its worst in the last week 2) describe your pain at its least in the last week 3) describe your pain on the average 4) describe your pain right now.\n\nThis outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased pain and negative values indicating decreased pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.'}, {'type': 'PRIMARY', 'title': 'Health-Related Quality of Life: Physical Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4', 'groupId': 'OG000', 'lowerLimit': '-7.2', 'upperLimit': '2.3'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-6.2', 'upperLimit': '5.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 8 weeks', 'description': 'Physical function was assessed using the 10-item Oswestry Disability Index (ODI). This measure\'s total score (0-100) reflects the percent of chronic low back pain related disability "today".\n\nThis outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased disability and negative values indicating decreased disability.', 'unitOfMeasure': 'percentage disability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.'}, {'type': 'PRIMARY', 'title': 'Health-Related Quality of Life: Physical Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.0', 'groupId': 'OG000', 'lowerLimit': '-9.7', 'upperLimit': '-0.2'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '-4.3', 'upperLimit': '7.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 26 weeks', 'description': 'Physical function was assessed using the 10-item Oswestry Disability Index (ODI). This measure\'s total score (0-100) reflects the percent of chronic low back pain related disability "today".\n\nThis outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased disability and negative values indicating decreased disability.', 'unitOfMeasure': 'percentage disability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.'}, {'type': 'SECONDARY', 'title': 'Opioid Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.1', 'groupId': 'OG000', 'lowerLimit': '-32.5', 'upperLimit': '18.3'}, {'value': '-1.4', 'groupId': 'OG001', 'lowerLimit': '-32.3', 'upperLimit': '29.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 8 weeks', 'description': 'Daily opioid dose was assessed using the Timeline Followback Method which looked at the past 28 days of opioid use. Medication use reports were verified against the medication bottles. Daily opioid dose was standardized \\[daily morphine-equivalent dose (MED)\\] across different opioids for each participant.\n\nThis outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased daily opioid dose and negative values indicating decreased daily opioid dose.', 'unitOfMeasure': 'morphine-equivalent mg/day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.'}, {'type': 'SECONDARY', 'title': 'Opioid Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.1', 'groupId': 'OG000', 'lowerLimit': '-35.5', 'upperLimit': '15.2'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-31.4', 'upperLimit': '30.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 26 weeks', 'description': 'Daily opioid dose was assessed using the Timeline Followback Method which looked at the past 28 days of opioid use. Medication use reports were verified against the medication bottles. Daily opioid dose was standardized \\[daily morphine-equivalent dose (MED)\\] across different opioids for each participant.\n\nThis outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased daily opioid dose and negative values indicating decreased daily opioid dose.', 'unitOfMeasure': 'morphine-equivalent mg/day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Alcohol Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.', 'unitOfMeasure': 'percentage using alcohol', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Alcohol Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.', 'unitOfMeasure': 'percentage using alcohol', 'reportingStatus': 'POSTED', 'populationDescription': 'One Meditation-CBT participant did not provide data for this measure at 8 week follow-up. Results for this measure are based on the number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Alcohol Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '38.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks', 'description': 'Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.', 'unitOfMeasure': 'percentage using alcohol', 'reportingStatus': 'POSTED', 'populationDescription': 'One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26 week follow-up. Results for this measure are based on the number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Drug Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '14.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.', 'unitOfMeasure': 'percentage using drugs', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Drug Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.', 'unitOfMeasure': 'percentage using drugs', 'reportingStatus': 'POSTED', 'populationDescription': 'One Meditation-CBT participant did not provide data for this measure at 8 week follow-up. Results for this measure are based on the number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Drug Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '26 weeks', 'description': 'Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.', 'unitOfMeasure': 'percentage using drugs', 'reportingStatus': 'POSTED', 'populationDescription': 'One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26 week follow-up. Results for this measure are based on the number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Chronic Pain Acceptance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '12.4'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '-4.7', 'upperLimit': '11.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 8 weeks', 'description': "Pain acceptance was assessed using the 20-item Chronic Pain Acceptance Questionnaire (CPAQ). This measure's total score (0-120) reflects one's degree of acceptance of their chronic pain, not specifying a time frame.\n\nThis outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased chronic pain acceptance and negative values indicating decreased chronic pain acceptance.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Chronic Pain Acceptance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '21.2'}, {'value': '9.3', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '17.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 26 weeks', 'description': "Pain acceptance was assessed using the 20-item Chronic Pain Acceptance Questionnaire (CPAQ). This measure's total score (0-120) reflects one's degree of acceptance of their chronic pain, not specifying a time frame.\n\nThis outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased chronic pain acceptance and negative values indicating decreased chronic pain acceptance.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Perceived Stress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '3.6'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-3.5', 'upperLimit': '3.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 8 weeks', 'description': 'Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10). This measure\'s total score (0-40) reflects the degree to which one perceives their life experiences as stressful "in the last month".\n\nThis outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased perceived stress and negative values indicating decreased perceived stress.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Perceived Stress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'groupId': 'OG000', 'lowerLimit': '-4.8', 'upperLimit': '1.3'}, {'value': '-1.8', 'groupId': 'OG001', 'lowerLimit': '-5.6', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 26 weeks', 'description': 'Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10). This measure\'s total score (0-40) reflects the degree to which one perceives their life experiences as stressful "in the last month".\n\nThis outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased perceived stress and negative values indicating decreased perceived stress.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mental Health Symptom Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.1'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '0.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 8 weeks', 'description': 'Mental Health Symptom Severity was assessed using the 90-item Symptom Checklist - Revised (SCL-90-R). This measure\'s Global Severity Index (i.e. total score, 0-360) reflects the degree of severity of mental health symptom distress "during the past 7 days".\n\nThis outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of mental health symptom distress and negative values indicating decreased mental health symptom distress.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mental Health Symptom Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '-0.01'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '-0.04'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 26 weeks', 'description': 'Mental Health Symptom Severity was assessed using the 90-item Symptom Checklist - Revised (SCL-90-R). This measure\'s Global Severity Index (i.e. total score, 0-360) reflects the degree of severity of mental health symptom distress "during the past 7 days".\n\nThis outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased levels of mental health symptom distress and negative values indicating decreased mental health symptom distress.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Depression Symptom Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.3'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '0.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 8 weeks', 'description': 'Depression symptom severity was assessed using the depression subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure\'s 13-item Depression subscale (0-52) reflects the degree of severity of distress from depression symptoms "during the past 7 days".\n\nThis outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of distress from depression symptoms and negative values indicating decreased levels of distress from depression symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Depression Symptom Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '0.02'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '-0.02'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 26 weeks', 'description': 'Depression symptom severity was assessed using the depression subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure\'s 13-item Depression subscale (0-52) reflects the degree of severity of distress from depression symptoms "during the past 7 days".\n\nThis outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased levels of distress from depression symptoms and negative values indicating decreased levels of distress from depression symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Anxiety Symptom Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '0.1'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '0.03'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 8 weeks', 'description': 'Anxiety symptom severity was assessed using the anxiety subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure\'s 10-item Anxiety subscale (0-40) reflects the degree of severity of distress from anxiety symptoms "during the past 7 days".\n\nThis outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of distress from anxiety symptoms and negative values indicating decreased levels of distress from anxiety symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Anxiety Symptom Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '0.05'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '0.02'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 26 weeks', 'description': 'Anxiety symptom severity was assessed using the anxiety subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure\'s 10-item Anxiety subscale (0-40) reflects the degree of severity of distress from anxiety symptoms "during the past 7 days".\n\nThis outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased levels of distress from anxiety symptoms and negative values indicating decreased levels of distress from anxiety symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Emotion Regulation Difficulty', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-8.3', 'upperLimit': '6.7'}, {'value': '-1.6', 'groupId': 'OG001', 'lowerLimit': '-10.7', 'upperLimit': '7.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 8 weeks', 'description': "Emotion regulation difficulty was assessed using the 36-item Difficulties in Emotion Regulation Scale (DERS). This measure's total score (36-180) reflects the severity of emotion regulation difficulty (no timeframe specified).\n\nThis outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased emotion regulation difficulty and negative values indicating decreased emotion regulation difficulty.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Emotion Regulation Difficulty', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.0', 'groupId': 'OG000', 'lowerLimit': '-11.7', 'upperLimit': '3.6'}, {'value': '-4.2', 'groupId': 'OG001', 'lowerLimit': '-13.5', 'upperLimit': '5.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 26 weeks', 'description': "Emotion regulation difficulty was assessed using the 36-item Difficulties in Emotion Regulation Scale (DERS). This measure's total score (36-180) reflects the severity of emotion regulation difficulty (no timeframe specified).\n\nThis outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased emotion regulation difficulty and negative values indicating decreased emotion regulation difficulty.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'C-Reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '-0.1'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.9', 'upperLimit': '1.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 8 weeks', 'description': 'Serum levels of C-reactive protein were used to assess the potential biological effects of the intervention. Normal values for C-reactive protein fall between 0 and 1 mg/dL; higher levels may indicate inflammatory or infectious processes.\n\nThis outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure).', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Three Meditation-CBT participants did not provide biological data at 8 week follow-up. Results for this measure are based on the number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'C-Reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '0.1'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.9', 'upperLimit': '1.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 26 weeks', 'description': 'Serum levels of C-reactive protein were used to assess the potential biological effects of the intervention. Normal values for C-reactive protein fall between 0 and 1 mg/dL; higher levels may indicate inflammatory or infectious processes.\n\nThis outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure).', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Six Meditation-CBT participants and one Wait-list Control participant did not provide biological data at 26 week follow-up. Results for this measure are based on the number of participants analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Economic Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '16443', 'spread': '15634', 'groupId': 'OG000'}, {'value': '14284', 'spread': '11091', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months prior to baseline, to baseline (enrollment)', 'description': 'Cost of medications, health care utilization, motor vehicle accidents (MVAs), and lost productivity were assessed.\n\nMedications (past month - self-report, verified against medication bottles): opioids (Timeline Followback), other medications (average daily use); costs for the past 6 months were calculated. Health care utilization (past 6 months): self-reported number of outpatient (medical, mental health, urgent care) and emergency department visits; number of inpatient days. Lost productivity (past 6 months): self-report number of missed work and leisure days. MVAs (past 6 months): self-report number of MVAs.\n\nCost Sources: Medications - rxpricequotes.com (primary), drugs.com (secondary), walgreens.com (tertiary). Health care utilization - WI Price Point System, Medical Expenditure Panel Survey. MVAs - National Safety Council. Lost productivity - U.S. Dept of Labor (average daily wage for a WI worker for work days; 8-hours of the federal minimum wage for lost leisure day).', 'unitOfMeasure': 'dollars', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Economic Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Usual Care Participants receiving usual care for CLBP and opioid therapy management.'}], 'classes': [{'categories': [{'measurements': [{'value': '11576', 'spread': '8347', 'groupId': 'OG000'}, {'value': '11697', 'spread': '9876', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From enrollment to 26 week follow-up (6 months)', 'description': 'Cost of medications, health care utilization, motor vehicle accidents (MVAs), and lost productivity were assessed.\n\nMedications (past month - self-report, verified against medication bottles): opioids (Timeline Followback), other medications (average daily use); costs for the past 6 months were calculated. Health care utilization (past 6 months): self-reported number of outpatient (medical, mental health, urgent care) and emergency department visits; number of inpatient days. Lost productivity (past 6 months): self-report number of missed work and leisure days. MVAs (past 6 months): self-report number of MVAs.\n\nCost Sources: Medications - rxpricequotes.com (primary), drugs.com (secondary), walgreens.com (tertiary). Health care utilization - WI Price Point System, Medical Expenditure Panel Survey. MVAs - National Safety Council. Lost productivity - U.S. Dept of Labor (average daily wage for a WI worker for work days; 8-hours of the federal minimum wage for lost leisure day).', 'unitOfMeasure': 'dollars', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One meditation-CBT participant did not provide data at 8-week follow-up; two participants (one meditation-CBT, one control) did not provide data at 26-week follow-up. All 35 participants were included in the analysis; missing participant data was imputed based on existing data for the given participant.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pain Sensitivity to Experimental Thermal Stimuli', 'timeFrame': '0, 8, 26 weeks', 'description': 'Pain sensitivity to thermal stimuli was assessed using standard psychophysical procedures. Thermal stimuli, ranging from 43 to 49oC, were applied to the thenar eminence of the right hand. Each stimulus was rated on two separate, validated 0-20 category-ratio scales assessing pain intensity and unpleasantness.', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Meditation-CBT', 'description': 'Meditation-CBT + Usual Care\n\nParticipants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.'}, {'id': 'FG001', 'title': 'Wait-list Control', 'description': 'Usual Care\n\nParticipants receiving usual care for CLBP and opioid therapy management.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'One experimental participant was unable to reach at 26 week follow up', 'groupId': 'FG000', 'numSubjects': '20'}, {'comment': 'One control participant was unable to reach at 26 week follow up', 'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental: Meditation-CBT', 'description': 'Mindfulness-CBT + Standard of Care Therapy\n\nMindfulness Based Intervention with Cognitive Behavioral Therapy (CBT) components: All study subjects receive standard of care therapy. In addition, experimental subjects receive the mindfulness-CBT. The intervention consists of an 8-week meditation-CBT course (2 hour weekly group sessions) and daily, at-home practice (30 mins/day, 6 days/week of formal practice). Controls will be offered meditation intervention after completing the study.'}, {'id': 'BG001', 'title': 'Wait-list Control', 'description': 'Standard of Care Therapy only'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.7', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '50.5', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '51.8', 'spread': '9.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Physical Function', 'classes': [{'categories': [{'measurements': [{'value': '68.1', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '64.5', 'spread': '14.1', 'groupId': 'BG001'}, {'value': '66.7', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Physical function was assessed using the 10-item Oswestry Disability Index. This measure\'s total score (0-100) reflects the percent of chronic low back pain related disability "today". Zero to 20% is considered "minimal disability", 21 to 40% "moderate disability", 41 to 60% "severe disability", 61 to 80% "crippled", and 81 to 100% "bed bound".', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Averaged Pain', 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '4.9', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '5.8', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Averaged pain is the average of 4 responses on a 0-10 numerical rating scale (0=no pain; 10=worst possible pain) from the Brief Pain Inventory (BPI): 1) describe your pain at its worst in the last week 2) describe your pain at its least in the last week 3) describe your pain on the average 4) describe your pain right now.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Opioid Use', 'classes': [{'categories': [{'measurements': [{'value': '166.9', 'spread': '153.7', 'groupId': 'BG000'}, {'value': '120.3', 'spread': '76.9', 'groupId': 'BG001'}, {'value': '148.3', 'spread': '129.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Opioid use was measured using the Timeline Followback Method which looked at the past 28 days of opioid use. Opioid use was standardized \\[daily morphine-equivalent dose (MED)\\] across different opioids for each participant.', 'unitOfMeasure': 'mg/day', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-11', 'studyFirstSubmitDate': '2013-01-22', 'resultsFirstSubmitDate': '2014-11-26', 'studyFirstSubmitQcDate': '2013-01-22', 'lastUpdatePostDateStruct': {'date': '2016-05-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-26', 'studyFirstPostDateStruct': {'date': '2013-01-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Alcohol Use', 'timeFrame': 'Baseline', 'description': 'Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.'}, {'measure': 'Alcohol Use', 'timeFrame': '8 weeks', 'description': 'Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.'}, {'measure': 'Alcohol Use', 'timeFrame': '26 weeks', 'description': 'Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.'}, {'measure': 'Drug Use', 'timeFrame': 'Baseline', 'description': 'Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.'}, {'measure': 'Drug Use', 'timeFrame': '8 weeks', 'description': 'Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.'}, {'measure': 'Drug Use', 'timeFrame': '26 weeks', 'description': 'Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.'}, {'measure': 'Chronic Pain Acceptance', 'timeFrame': 'baseline to 8 weeks', 'description': "Pain acceptance was assessed using the 20-item Chronic Pain Acceptance Questionnaire (CPAQ). This measure's total score (0-120) reflects one's degree of acceptance of their chronic pain, not specifying a time frame.\n\nThis outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased chronic pain acceptance and negative values indicating decreased chronic pain acceptance."}, {'measure': 'Chronic Pain Acceptance', 'timeFrame': 'baseline to 26 weeks', 'description': "Pain acceptance was assessed using the 20-item Chronic Pain Acceptance Questionnaire (CPAQ). This measure's total score (0-120) reflects one's degree of acceptance of their chronic pain, not specifying a time frame.\n\nThis outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased chronic pain acceptance and negative values indicating decreased chronic pain acceptance."}, {'measure': 'Perceived Stress', 'timeFrame': 'baseline to 8 weeks', 'description': 'Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10). This measure\'s total score (0-40) reflects the degree to which one perceives their life experiences as stressful "in the last month".\n\nThis outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased perceived stress and negative values indicating decreased perceived stress.'}, {'measure': 'Perceived Stress', 'timeFrame': 'baseline to 26 weeks', 'description': 'Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10). This measure\'s total score (0-40) reflects the degree to which one perceives their life experiences as stressful "in the last month".\n\nThis outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased perceived stress and negative values indicating decreased perceived stress.'}, {'measure': 'Mental Health Symptom Severity', 'timeFrame': 'baseline to 8 weeks', 'description': 'Mental Health Symptom Severity was assessed using the 90-item Symptom Checklist - Revised (SCL-90-R). This measure\'s Global Severity Index (i.e. total score, 0-360) reflects the degree of severity of mental health symptom distress "during the past 7 days".\n\nThis outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of mental health symptom distress and negative values indicating decreased mental health symptom distress.'}, {'measure': 'Mental Health Symptom Severity', 'timeFrame': 'baseline to 26 weeks', 'description': 'Mental Health Symptom Severity was assessed using the 90-item Symptom Checklist - Revised (SCL-90-R). This measure\'s Global Severity Index (i.e. total score, 0-360) reflects the degree of severity of mental health symptom distress "during the past 7 days".\n\nThis outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased levels of mental health symptom distress and negative values indicating decreased mental health symptom distress.'}, {'measure': 'Depression Symptom Severity', 'timeFrame': 'baseline to 8 weeks', 'description': 'Depression symptom severity was assessed using the depression subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure\'s 13-item Depression subscale (0-52) reflects the degree of severity of distress from depression symptoms "during the past 7 days".\n\nThis outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of distress from depression symptoms and negative values indicating decreased levels of distress from depression symptoms.'}, {'measure': 'Depression Symptom Severity', 'timeFrame': 'baseline to 26 weeks', 'description': 'Depression symptom severity was assessed using the depression subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure\'s 13-item Depression subscale (0-52) reflects the degree of severity of distress from depression symptoms "during the past 7 days".\n\nThis outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased levels of distress from depression symptoms and negative values indicating decreased levels of distress from depression symptoms.'}, {'measure': 'Anxiety Symptom Severity', 'timeFrame': 'baseline to 8 weeks', 'description': 'Anxiety symptom severity was assessed using the anxiety subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure\'s 10-item Anxiety subscale (0-40) reflects the degree of severity of distress from anxiety symptoms "during the past 7 days".\n\nThis outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of distress from anxiety symptoms and negative values indicating decreased levels of distress from anxiety symptoms.'}, {'measure': 'Anxiety Symptom Severity', 'timeFrame': 'baseline to 26 weeks', 'description': 'Anxiety symptom severity was assessed using the anxiety subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure\'s 10-item Anxiety subscale (0-40) reflects the degree of severity of distress from anxiety symptoms "during the past 7 days".\n\nThis outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased levels of distress from anxiety symptoms and negative values indicating decreased levels of distress from anxiety symptoms.'}, {'measure': 'Emotion Regulation Difficulty', 'timeFrame': 'baseline to 8 weeks', 'description': "Emotion regulation difficulty was assessed using the 36-item Difficulties in Emotion Regulation Scale (DERS). This measure's total score (36-180) reflects the severity of emotion regulation difficulty (no timeframe specified).\n\nThis outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased emotion regulation difficulty and negative values indicating decreased emotion regulation difficulty."}, {'measure': 'Emotion Regulation Difficulty', 'timeFrame': 'baseline to 26 weeks', 'description': "Emotion regulation difficulty was assessed using the 36-item Difficulties in Emotion Regulation Scale (DERS). This measure's total score (36-180) reflects the severity of emotion regulation difficulty (no timeframe specified).\n\nThis outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased emotion regulation difficulty and negative values indicating decreased emotion regulation difficulty."}, {'measure': 'C-Reactive Protein', 'timeFrame': 'baseline to 8 weeks', 'description': 'Serum levels of C-reactive protein were used to assess the potential biological effects of the intervention. Normal values for C-reactive protein fall between 0 and 1 mg/dL; higher levels may indicate inflammatory or infectious processes.\n\nThis outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure).'}, {'measure': 'C-Reactive Protein', 'timeFrame': 'baseline to 26 weeks', 'description': 'Serum levels of C-reactive protein were used to assess the potential biological effects of the intervention. Normal values for C-reactive protein fall between 0 and 1 mg/dL; higher levels may indicate inflammatory or infectious processes.\n\nThis outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure).'}, {'measure': 'Economic Outcomes', 'timeFrame': '6 months prior to baseline, to baseline (enrollment)', 'description': 'Cost of medications, health care utilization, motor vehicle accidents (MVAs), and lost productivity were assessed.\n\nMedications (past month - self-report, verified against medication bottles): opioids (Timeline Followback), other medications (average daily use); costs for the past 6 months were calculated. Health care utilization (past 6 months): self-reported number of outpatient (medical, mental health, urgent care) and emergency department visits; number of inpatient days. Lost productivity (past 6 months): self-report number of missed work and leisure days. MVAs (past 6 months): self-report number of MVAs.\n\nCost Sources: Medications - rxpricequotes.com (primary), drugs.com (secondary), walgreens.com (tertiary). Health care utilization - WI Price Point System, Medical Expenditure Panel Survey. MVAs - National Safety Council. Lost productivity - U.S. Dept of Labor (average daily wage for a WI worker for work days; 8-hours of the federal minimum wage for lost leisure day).'}, {'measure': 'Economic Outcomes', 'timeFrame': 'From enrollment to 26 week follow-up (6 months)', 'description': 'Cost of medications, health care utilization, motor vehicle accidents (MVAs), and lost productivity were assessed.\n\nMedications (past month - self-report, verified against medication bottles): opioids (Timeline Followback), other medications (average daily use); costs for the past 6 months were calculated. Health care utilization (past 6 months): self-reported number of outpatient (medical, mental health, urgent care) and emergency department visits; number of inpatient days. Lost productivity (past 6 months): self-report number of missed work and leisure days. MVAs (past 6 months): self-report number of MVAs.\n\nCost Sources: Medications - rxpricequotes.com (primary), drugs.com (secondary), walgreens.com (tertiary). Health care utilization - WI Price Point System, Medical Expenditure Panel Survey. MVAs - National Safety Council. Lost productivity - U.S. Dept of Labor (average daily wage for a WI worker for work days; 8-hours of the federal minimum wage for lost leisure day).'}, {'measure': 'Pain Sensitivity to Experimental Thermal Stimuli', 'timeFrame': '0, 8, 26 weeks', 'description': 'Pain sensitivity to thermal stimuli was assessed using standard psychophysical procedures. Thermal stimuli, ranging from 43 to 49oC, were applied to the thenar eminence of the right hand. Each stimulus was rated on two separate, validated 0-20 category-ratio scales assessing pain intensity and unpleasantness.'}], 'primaryOutcomes': [{'measure': 'Health-Related Quality of Life: Averaged Pain Severity', 'timeFrame': 'baseline to 8 weeks', 'description': 'Averaged pain is the average of 4 responses on a 0-10 numerical rating scale (0=no pain; 10=worst possible pain) from the Brief Pain Inventory (BPI): 1) describe your pain at its worst in the last week 2) describe your pain at its least in the last week 3) describe your pain on the average 4) describe your pain right now.\n\nThis outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased pain and negative values indicating decreased pain.'}, {'measure': 'Health-Related Quality of Life: Averaged Pain Severity', 'timeFrame': 'baseline to 26 weeks', 'description': 'Averaged pain is the average of 4 responses on a 0-10 numerical rating scale (0=no pain; 10=worst possible pain) from the Brief Pain Inventory (BPI): 1) describe your pain at its worst in the last week 2) describe your pain at its least in the last week 3) describe your pain on the average 4) describe your pain right now.\n\nThis outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased pain and negative values indicating decreased pain.'}, {'measure': 'Health-Related Quality of Life: Physical Function', 'timeFrame': 'baseline to 8 weeks', 'description': 'Physical function was assessed using the 10-item Oswestry Disability Index (ODI). This measure\'s total score (0-100) reflects the percent of chronic low back pain related disability "today".\n\nThis outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased disability and negative values indicating decreased disability.'}, {'measure': 'Health-Related Quality of Life: Physical Function', 'timeFrame': 'baseline to 26 weeks', 'description': 'Physical function was assessed using the 10-item Oswestry Disability Index (ODI). This measure\'s total score (0-100) reflects the percent of chronic low back pain related disability "today".\n\nThis outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased disability and negative values indicating decreased disability.'}], 'secondaryOutcomes': [{'measure': 'Opioid Dose', 'timeFrame': 'baseline to 8 weeks', 'description': 'Daily opioid dose was assessed using the Timeline Followback Method which looked at the past 28 days of opioid use. Medication use reports were verified against the medication bottles. Daily opioid dose was standardized \\[daily morphine-equivalent dose (MED)\\] across different opioids for each participant.\n\nThis outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased daily opioid dose and negative values indicating decreased daily opioid dose.'}, {'measure': 'Opioid Dose', 'timeFrame': 'baseline to 26 weeks', 'description': 'Daily opioid dose was assessed using the Timeline Followback Method which looked at the past 28 days of opioid use. Medication use reports were verified against the medication bottles. Daily opioid dose was standardized \\[daily morphine-equivalent dose (MED)\\] across different opioids for each participant.\n\nThis outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased daily opioid dose and negative values indicating decreased daily opioid dose.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Pain', 'Low Back Pain'], 'conditions': ['Chronic Pain', 'Low Back Pain']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Dr. Zgierska was supported by the K23AA017508 from the National Institutes of Health (NIH) National Institute on Alcohol Abuse and Alcoholism (NIAAA). The project was also supported by the Clinical and Translational Science Award (CTSA) program through the NIH National Center for Advancing Translational Sciences (NCATS), grant UL1TR000427. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.'}, {'pmid': '26968850', 'type': 'DERIVED', 'citation': 'Zgierska AE, Burzinski CA, Cox J, Kloke J, Stegner A, Cook DB, Singles J, Mirgain S, Coe CL, Backonja M. Mindfulness Meditation and Cognitive Behavioral Therapy Intervention Reduces Pain Severity and Sensitivity in Opioid-Treated Chronic Low Back Pain: Pilot Findings from a Randomized Controlled Trial. Pain Med. 2016 Oct;17(10):1865-1881. doi: 10.1093/pm/pnw006. Epub 2016 Mar 10.'}]}, 'descriptionModule': {'briefSummary': 'Chronic low back pain (CLBP) is one of the most common, costly and disabling conditions. It is often refractory to treatment, with patients requiring long-term opioid therapy. Mindfulness meditation is a promising treatment for chronic pain, mental health and addictive disorders. When combined with cognitive behavioral therapy (CBT), a standard of care for CLBP, it may produce additive benefits. The goal of this randomized controlled trial (RCT) is to evaluate the feasibility and efficacy of an innovative behavioral intervention to improve the health of adults with opioid-treated CLBP. This RCT will test the hypotheses that, at 26 weeks, meditation-CBT group participants (meditation-CBT + usual care), compared to those in a wait-list control group (usual care alone), will improve health-related quality of life (primary outcomes: pain severity and physical function) and reduce opioid medication use (secondary outcome). In addition, they will also decrease alcohol and drug use/misuse, and improve stress-sensitive measures and economic outcomes.', 'detailedDescription': 'Chronic low back pain (CLBP) is one of the most common, costly and disabling conditions. Treatment for refractory CLBP includes long-term opioid therapy even though it is often only marginally effective. Prescription opioid abuse is a national epidemic. Development of safe, effective non-addictive therapies for chronic pain is a national priority. Mindfulness meditation is a promising, safe treatment for chronic pain, mental health and addictive disorders. When combined with cognitive behavioral therapy (CBT), a standard of care for CLBP, it may produce additive benefits. No study has evaluated the potential of a combined meditation-CBT intervention to improve outcomes in patients with opioid-treated CLBP.\n\nThis unblinded 26-week pilot randomized controlled trial (RCT) will test methods feasibility and efficacy of meditation-CBT for improving health-related quality of life (primary outcomes: pain severity and physical function) and reduce opioid medication use (secondary outcome) among adults with opioid-treated CLBP. Eligible participants are adults at least 21 years old, with daily CLBP treated with daily opioids (at least 30 morphine-equivalent mg/day) for at least 3 months. They will be recruited from outpatient clinic and community settings, and randomly assigned to one of two study arms: meditation-CBT + usual care or usual care alone. The targeted meditation-CBT intervention will consist of a) therapist-led group training (two-hours/week for 8 weeks), and b) at-home meditation practice (at least 30 minutes/day, 6 days/week). Control participants will be offered the intervention after their study completion.\n\nOutcome measures, collected at 0, 8 (directly post-intervention) and 26 (18 weeks post-intervention) weeks will gather data on efficacy and potential mechanisms of action of meditation-CBT intervention. This RCT will test the hypotheses that, at 26 weeks, meditation-CBT group participants (meditation-CBT + usual care), compared to those in a wait-list control group (usual care alone), will improve health-related quality of life (primary outcomes: pain severity and physical function) and reduce opioid medication use (secondary outcome). In addition, they will also decrease alcohol and drug use/misuse, and improve stress-sensitive measures and economic outcomes. Increased pain acceptance, mindfulness level or stress reduction are hypothesized to be the mechanistic pathways.\n\nThis study directly addresses national priorities aimed at the development of an effective, safe treatment for CLBP and reduction of opioid use. Potential benefits accruing from positive findings include improved quality of life and reduced opioid pain medication use among patients with refractory, opioid-treated CLBP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 21 years old\n* Chronic low back pain defined as a daily pain in the lumbosacral region or radiating to the leg (sciatica)\n* Pain lasting for and treated with clinician-prescribed daily opioids (≥ 30mg of morphine equivalent dose, MED) for ≥ 3 months\n* Has the ability to feel warm and cold temperature sensations in both hands (for pain psychophysical testing)\n* English fluent\n\nExclusion Criteria:\n\n* Experience in meditation (current, regular practice in the past 12 months or past formal training)\n* Inability to reliably participate\n* Self-reported current pregnancy\n* Preexisting delusional, bipolar, or borderline personality disorders\n* Individuals lacking consent capacity and prisoners'}, 'identificationModule': {'nctId': 'NCT01775995', 'briefTitle': 'Meditation-CBT for Opioid-treated Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Randomized Controlled Trial of Mindfulness Meditation and Cognitive Behavioral Therapy Intervention for Opioid-treated Chronic Low Back Pain', 'orgStudyIdInfo': {'id': '2012-0656'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meditation-CBT', 'description': 'Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.', 'interventionNames': ['Behavioral: Meditation-CBT Intervention + Usual Care']}, {'type': 'OTHER', 'label': 'Wait-list Control', 'description': 'Participants receiving usual care for CLBP and opioid therapy management.', 'interventionNames': ['Other: Usual Care Alone']}], 'interventions': [{'name': 'Meditation-CBT Intervention + Usual Care', 'type': 'BEHAVIORAL', 'otherNames': ['Mindfulness Meditation', 'Meditation', 'Mindfulness', 'Usual care', 'Cognitive Behavioral Therapy'], 'description': 'The intervention combines meditation and standard-of-care CBT strategies for chronic low back pain. It consists of eight weekly 2-hour group sessions guided by trained instructors. In addition to session attendance, experimental participants are asked to practice meditation at home at least 6 days/week, 30 minutes/day during the 26-week study.\n\nControl participants will be offered the intervention after completing the study.\n\nAll participants receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.', 'armGroupLabels': ['Meditation-CBT']}, {'name': 'Usual Care Alone', 'type': 'OTHER', 'description': 'All participants receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.', 'armGroupLabels': ['Wait-list Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53715', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin-Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Aleksandra Zgierska, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}